Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients

This study has been completed.

Sponsor:

Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT00734552

First Posted: August 14, 2008

Last Update Posted: May 22, 2015

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Compound α-Keto Acid: The daily dose of compound α-Keto Acid is 0.1/kg/d. The total daily dose will be divided into three times a day.

Low Protein Diet: Diet contain protein 0.8g/kg/d.

Other Name: Test Group

2

Normal protein diet

Dietary Supplement: Normal protein diet

Diet contain protein 1.0-1.2 g/kg/d.

Other Name: Control Group

Detailed Description:

Residual renal function (RRF) is associated with cardiovascular complication, nutritional status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients. Therefore, RRF is an important determinant of mortality and morbidity in PD patients.

Previous studies have suggested that dietary protein restriction supplemented with compound keto/amino acids may slow the loss of RRF in chronic kidney disease patients. However, there is very few reports to address the effect of compound keto/amino acid supplementation in RRF in PD patients.

The aim of this study is to evaluate the protective effect of compound α-Keto Acid plus low protein diet in RRF in PD Patients.This is a randomized, open-label, prospective study. 100 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. α-Keto Acid group will use compound α-Keto Acid plus low protein diet, while control group will use normal protein diet.Compound α-Keto Acid dosage is 0.1/kg/d daily. The effect of compound α-Keto Acid plus low protein diet in RRF will be evaluated after 1 year treatment.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

20 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients on PD at least one month prior to study entry.

Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old.

Residual GFR ≥3 ml/min/1.73m2.

Residual urine volume ≥ 500 ml/24h.

No history of taking α-Keto Acid within 2 weeks.

Subjects who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

History of peritonitis or other infection within one month.

History of taking drug which may affect amino acid metabolism within one month.